(88 days)
Not Found
No
The description focuses on mechanical vibration and visual feedback based on muscle contraction, with no mention of AI or ML algorithms for analysis, control, or feedback.
Yes
The device is intended for "strengthening of the pelvic floor muscles to treat women with stress urinary incontinence," which falls under the definition of therapeutic treatment.
No
The device description indicates that the Flyte System is designed to deliver treatment and provide feedback on muscle contraction during Kegel exercises, rather than diagnose a medical condition.
No
The device description explicitly states the product consists of a wand and a hand-held controller, which are physical hardware components.
Based on the provided information, the Flyte System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "strengthening of the pelvic floor muscles to treat women with stress urinary incontinence." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device description details a system that delivers mechanical vibrations and provides feedback during Kegel exercises. This is a physical intervention and monitoring system, not a device that analyzes biological samples (which is characteristic of IVDs).
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device interacts directly with the body for therapeutic and feedback purposes.
In summary, the Flyte System is a therapeutic device intended for physical therapy and muscle strengthening, not a diagnostic device that analyzes samples to provide information about a patient's health status.
N/A
Intended Use / Indications for Use
The Flyte System is intended for strengthening of the pelvic floor muscles to treat women with stress urinary incontinence.
Product codes (comma separated list FDA assigned to the subject device)
HIR
Device Description
The Flyte System is a repeat use, non-sterile, vaginal device intended to condition and strengthen the pelvic floor muscle (PFM) system. The Flyte System is designed for in-home use to deliver treatment to the pelvic floor muscles during normal Kegel exercises. The product consists of a wand and a hand-held controller. The Flyte wand is placed in the vagina and delivers a series of mechanical vibrations while the pelvic floor muscles are contracting.
The hand-held controller controls the wand, guides the user through the treatment session and provides a visual feedback function to inform the user when the correct muscles are being contracted during a Kegel exercise. The wand provides a resistive surface against which the user can contract the PFM, and houses an electric motor containing an eccentric weight that generates mechanical oscillations when the motor is running. A cable connects the wand and the controller.
Controller: The controller consists of a 3.7V Lithium-ion Polymer rechargeable battery with a capacity of 700-750 mAh and built-in safety protection. The controller also contains a PCB assembly used to control the motor speed and frequency and to provide the user with visual feedback information. The controller housing is made of ABS plastic (Acrylonitrile-butadiene-styrene copolymer).
Wand: The wand contains an accelerometer and gyroscope which enable the Controller to generate the visual feedback information. It also houses the motor and weight used to generate the mechanical vibrations. The wand is available in Large and Small sizes. The wand housing is cylindrical and is made of ABS plastic. The wand is the only part of the device that directly contacts the user's vaginal cavity (mucosal membrane contact, ≤24hr) and is covered entirely with a biocompatible medical-grade silicone sheath.
Additional Components:
Charging Cable: Connects the Controller to the Charging Block Charging Block: AC adapter that allows you to plug the Controller into a wall outlet for charging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vagina-Pelvic floor muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
in-home use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Given the changes proposed in this submission were limited to minor labeling changes, no clinical and non-clinical performance data was submitted in this submission to support the changes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.1425 Perineometer.
(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 29, 2023
Pelvital USA, Inc. Pamela Snyder Correspondent & Consultant 860 Blue Gentian Rd. Suite 200 Eagan, Minnesota 55121
Re: K233362
Trade/Device Name: Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) Regulation Number: 21 CFR 884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: HIR Dated: December 11, 2023 Received: December 11, 2023
Dear Pamela Snyder:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica K. Nguyen -S
Jessica K.Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Flyte System
Indications for Use (Describe)
The Flyte System is intended for strengthening of the pelvic floor muscles to treat women with stress urinary incontinence.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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3
510(k) Summary
Special 510(k) Submission: Labeling Modification Flyte System
Applicant & Manufacturer
Pelvital USA, Inc. 860 Blue Gentian Rd. Suite 200 Eagan, MN 55121 866-735-8482
Applicant Contact
Lydia Zeller President & CEO lydia.zeller@pelvital.com 612-643-9724
Date Prepared: December 29, 2023
Device Identification
Trade names: The Flyte System or Flyte or MTI-1.0. Common Name: Perineometer Product Code: HIR Classification Panel: Obstetrics/Gynecology Regulation Number: 21 CFR § 884.14251 Classification Name: Perineometer
Legally Marketed Predicate
K212655 Flyte System The predicate devices have not been subject to a design-related recall.
Device Description
The Flyte System is a repeat use, non-sterile, vaginal device intended to condition and strengthen the pelvic floor muscle (PFM) system. The Flyte System is designed for in-home use to deliver treatment to the pelvic floor muscles during normal Kegel exercises. The product consists of a wand and a hand-held controller. The Flyte wand is placed in the vagina and delivers a series of mechanical vibrations while the pelvic floor muscles are contracting.
The hand-held controller controls the wand, guides the user through the treatment session and provides a visual feedback function to inform the user when the correct muscles are being contracted during a Kegel exercise. The wand provides a resistive surface against which the user can contract the PFM, and houses an electric motor containing an eccentric weight that
4
generates mechanical oscillations when the motor is running. A cable connects the wand and the controller.
Controller: The controller consists of a 3.7V Lithium-ion Polymer rechargeable battery with a capacity of 700-750 mAh and built-in safety protection. The controller also contains a PCB assembly used to control the motor speed and frequency and to provide the user with visual feedback information. The controller housing is made of ABS plastic (Acrylonitrile-butadienestyrene copolymer).
Wand: The wand contains an accelerometer and gyroscope which enable the Controller to generate the visual feedback information. It also houses the motor and weight used to generate the mechanical vibrations. The wand is available in Large and Small sizes. The wand housing is cylindrical and is made of ABS plastic. The wand is the only part of the device that directly contacts the user's vaginal cavity (mucosal membrane contact, ≤24hr) and is covered entirely with a biocompatible medical-grade silicone sheath.
Additional Components:
Charging Cable: Connects the Controller to the Charging Block Charging Block: AC adapter that allows you to plug the Controller into a wall outlet for charging.
Indications for Use
The Flyte System is intended for strengthening of the pelvic floor muscles to treat women with stress urinary incontinence.
Substantial Equivalence Summary
The Special 510(k) is a Labeling Modification to the Flyte System, predicate K212655. There are no changes to the Flye System device or principles of operation. The predicate and subject device are identical. A summary of the technological feature comparison is included in the SE table for completeness.
| K233362 Under review | Predicate K212655 | Comparison | |
|---|---|---|---|
| Trade/Device Name | Flyte or Flyte System or Flyte | ||
| MTI-1.0.System | Flyte or Flyte System or | ||
| Flyte MTI-1.0. System | Identical | ||
| Manufacturer | Pelvital USA, Inc | Pelvital USA, Inc | Same Manufacturer |
| 510(k) Number | K233362 | K212655 | Same device |
| Regulation Number | 21 CFR § 884.1425 | 21 CFR § 884.1425 | Identical |
| Regulation Name | Perineometer | Perineometer | Identical |
| Regulatory Class | II | II | Identical |
| Product Code | HIR | HIR | Identical |
| K233362 Under review | Predicate K212655 | Comparison | |
| Over the Counter | |||
| (OTC) | Yes | Yes | Identical |
| Rx use was removed | |||
| Intended Use | Intended for strengthening of | ||
| the pelvic floor muscles | Intended for strengthening of | ||
| the pelvic floor muscles | Identical | ||
| Indications for Use | The Flyte System is intended | ||
| for strengthening of the pelvic | |||
| floor muscles to treat women | |||
| with stress urinary incontinence | The Pelvital System is | ||
| intended for the | |||
| strengthening of the pelvic | |||
| floor muscles, which has | |||
| been found to help women | |||
| with stress urinary | |||
| incontinence. | Similar | ||
| Same population | |||
| Same disease or | |||
| condition it treats. | |||
| Same intended use | |||
| Target Population | Women with urinary | ||
| incontinence | Women with urinary | ||
| incontinence | Identical | ||
| Anatomical Site | Vagina-Pelvic floor muscles | Vagina-Pelvic floor muscles | Identical |
| Single Patient Device | Yes | Yes | Identical |
| Single Use or | |||
| Reusable | Reusable | Reusable | Identical |
| Sterility | Non-Sterile; Clean | Non-sterile; Clean | Identical |
| Device Design | A handheld Controller and a | ||
| vaginally inserted Wand | A handheld control unit | ||
| and a vaginally inserted | |||
| Wand | Identical | ||
| Component name | |||
| changes from Control | |||
| unit/ Biofeedback unit | |||
| to Controller | |||
| Flyte Components | Wand | ||
| Controller | |||
| Charging Cable | |||
| Charging Block | Wand | ||
| Control Unit/ Biofeedback Unit | |||
| Charging Cable | |||
| Wall Charger | Identical Device | ||
| Component name | |||
| change from Control | |||
| unit to Controller | |||
| Visual feedback | |||
| Display | Yes | Yes | Identical |
| K233362 Under review | Predicate K212655 | Comparison | |
| Wand Dimensions | SMALL: | ||
| Max Shaft Diameter: 29 mm | |||
| Length: 97.85 mm | |||
| Weight: 89 +/- 1g | |||
| LARGE: | |||
| Max Shaft Diameter: 35 mm | |||
| Length:101 mm | |||
| Weight: 99+/- 2g | SMALL: | ||
| Max Shaft OD: 29 mm | |||
| Length: 97.85 mm | |||
| Weight: 89 +/- 1g | |||
| LARGE: | |||
| Max Shaft Diameter: 35 mm | |||
| Length:101 mm | |||
| Weight: 99+/- 2g | Identical | ||
| Technological Characteristics: The Devices are the Identical. There are No changes to the device. |
5
6
The changes that are the subject of this premarket notification are limited to minor changes to the indication for use statement and labeling. The Flyte System is substantially equivalent to the predicate, Flyte System K212655. The devices are manufactured by Pelvital USA, Inc. There are no changes to the device's technological characteristics, materials, or principles of operation. The devices are identical.
The Flyte System has the same intended use and the same technological characteristics as the previously cleared predicate device, K212655. The Indication for use clarifies the indication without affecting the substance or meaning of the indications or intended use. It does not alter the original intended use or therapeutic effect. There is no change to patient populations, demographics, diagnosis, prognosis, comorbidities, and/or potential for complications. The riskbased assessment included an analysis of both safety and effectiveness. The modifications do not increase the risk profile of the device. There are no changes to contraindications, warnings, or precautions. There are no new risks are modifications of risks.
Clinical and Non-clinical Performance Testing
Given the changes proposed in this submission were limited to minor labeling changes, no clinical and non-clinical performance data was submitted in this submission to support the changes.
Conclusion
The differences do not raise any different questions regarding safety and effectiveness. The Flyte System, as designed and manufactured, is substantially equivalent to the predicate device, K212655 Flyte System.